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FDA 510(k), K190719, Artemis Eye System
FDA 510(k), K190719, Artemis Eye System
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$149.00 USD
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510(K) Number: K190719
Device Name: Artemis Eye System
Manufacturer: Penumbra, Inc.
Device Classification Name: Endoscope, Neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 03/20/2019
Decision Date: 08/30/2019
Regulation Medical Specialty: Neurology
Device Name: Artemis Eye System
Manufacturer: Penumbra, Inc.
Device Classification Name: Endoscope, Neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 03/20/2019
Decision Date: 08/30/2019
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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